MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RIMMED SPEED PIN - 45MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 74013471

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/24/2023

Event Type  Injury  

Event Description

A trial tibia tray was inserted and pinned in place to confirm sizing and rotation.This was noted to just avoid the metal tibial interference screw so it did not have to be extracted.The anterior pin that was drilled contacted the interference screw and snapped, but the retained segment was threaded and buried in bone so was left in place so as not to disrupt any of the proximal metaphyseal bone.

• Brand Name: RIMMED SPEED PIN - 45MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 17097950
• MDR Text Key: 316973368
• Report Number: MW5118283
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74013471
• Device Lot Number: 19JNX0047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 91 KG